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Attachment 2 - Quality Assurance Surveillance Plan
| Performance Requirement |
| Performance Standard |
| Acceptable Quality Level |
| Method of Surveillance |
| Specimen Collection and Transport |
| Material supplied shall be designed to take an acceptable sample needed for testing. |
| All material must be in good working order and free from defects that would affect quality of test. |
| 100% inspection at MTF |
| Training |
| Training provided must be sufficient to ensure acceptable standards for testing. |
| Training must be provided as needed by the facility |
| 100% inspection at the MTF |
| Screening Test Changes |
| MTF shall receive at least 180 days advance notice of testing changes |
| 180 days advance notice or less |
| 100% inspection at the MTF |
| Lab Analysis |
| Newborn Screening for all disorders listed in this contract and secondary testing as appropriate. |
| Tests should be for all disorders listed with rescreening provided as necessary. |
| 100% inspection at the MTF |
| Test Results Timeline |
| Test Results provided within 5 business days but not longer than 7 business days of sample receipt. |
| 7 business days or less. |
| 100% inspection at the MTF |
| Test Results Method of delivery |
| Secure email, electronic post, or as a last resort mailed via USPS. All abnormal results of an urgent nature reported by phone. |
| Communication method utilized as dictated by results. |
| 100% inspection by MTF |